ATTUNE 1516-30-805Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295048107), received between Jul 11, 2018 and Dec 23, 2025 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MID FLEXION INSTABILITY. FEMUR AND TIBIA WERE WELL FIXED; RELEASED CAPSULE AND WAS ABLE TO BALANCE THE KNEE. DOI, (B)(6) 2024. DOR, (B)(6) 2025. AFFECTED SIDE, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23881487 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ATTUNE PRIMARY FEMUR AND INSERT. PATIENT EXPERIENCED PAIN POST PRIMARY TKA DUE TO OVERSIZED FEMORAL IMPLANT RESULTING IN POOR PATELLA TRACKING. REVISION SURGERY COMPLETELY WHERE DOWNSIZED FEMUR AND EXCHANGED INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19605592 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SWAPPED POLY OUT WITH THE SAME SIZE WAS PERFORMED. DOI: (B)(6) 2023. DOR: JANUARY 2, 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18475123 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE. PATIENT HAD FALLEN AND PATIENT WAS HAVING PAIN IN KNEE. SURGEON EXPLANTED THE IMPLANTS AND REVISED TO ATTUNE REVISION IMPLANTS. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 17817285 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 57.5 MONTHS. REASON FOR REVISION: ARTHROFIBROSIS.

  Patient problems: Adhesion(s)

  MAUDE report 16334563 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 17 MONTHS. REASON FOR REVISION: INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 16333932 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16204507 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY ATTUNE KNEE REPLACEMENT ON THE (B)(6) 2021 (NO PATELLA RESURFACING DONE DURING PRIMARY SURGERY). THE PATIENT HAS BEEN COMPLAINING OF GROWING ANTERIOR KNEE PAIN AND SOME SWELLING. SURGEON ELECTED TO RE-OPERATE AND RESURFACE THE PATELLA. DURING THIS PROCEDURE IT WAS ALSO NOTED THAT THE PATIENT HAD SIGNIFICANT SYNOVITIS WHICH WAS DEBRIDED AT THE TIME OF SURGERY.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15794380 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2021. DOI: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15727252 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D AND LINER EXCHANGE WAS PERFORMED DUE TO POSSIBLE INFECTION LEFT KNEE. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15524322 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION OF THE KNEE JOINT FROM PREVIOUS SURGERY. THE SURGEON PROCEEDED WITH IRRIGATION AND DEBRIDEMENT AND SWAPPED THE POLY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15192314 ↗
• MalfunctionJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DETAILS AS FOLLOWS: DATE OF SURGERY: (B)(6) 2021. SURGEON: MR (B)(6). PATIENT AGE: (B)(6). PATIENT DOB: (B)(6) PATIENT WEIGHT: (B)(6). PATIENT ACTIVITY LEVEL: ACTIVE YOUNG ADULT. EXPLANTED DEVICES: SIZE 7 TIBIA REF 150610007, LOT 8617449. SIZE 8 LEFT CR FEMORAL COMPONENT REF 1504-00-108, LOT DHUDH3. SIZE 8, CR RP REF 5MM REF 1516-30-805, LOT 7907632. THIS PRIMARY HAS BEEN REVISED TODAY DUE TO: TIBIAL SUBSIDENCE AND PAIN, WITH SYNOVITIS. INTRA-OPERATIVELY FOUND: SUSPECTED WEAR OF THE POLY INSERT CEMENT DEBRIS EMBEDDED IN POLY PATELLA, AND EMBEDDED IN POSTERIOR SURFACE OF POLY RP POLY INSERT POSTERIOR SIDE EVIDENCE OF THIRD BODY WEAR. REVISION ATTUNE KNEE IMPLANTS USED: REF 1506-60-007, SIZE 7 RP REVISION TIBIA, LOT 9597965. REF 1511-11-102, 37MM PARTIALLY COATED TIBIAL SLEEVE LOT JG4390. REF 1504-40-108, SIZE 8 LEFT CRS FEMORAL COMPONENT LOT J53X91. REF 1513-12-110, 12MM X 110MM STEM (ON TIBIA) LOT J5872H. REF 1513-14-110, 14MM X 110MM STEM (ON FEMUR) LOT JC3555. REF 1517-10-808, SIZE 8, 8MM AOX RP CRS INSERT LOT 9397810.

  Patient problems: Pain; Synovitis

  MAUDE report 13257395 ↗
• MalfunctionJul 23, 2021Difficult to Insert; Difficult to Insert

  AFTER PLACING THE DEFINITIVE ROTATING POLYETHYLENE OF THE TIBIA, IT PROVED TO BE UNSTABLE IN ROTATION, MAKING A SPIN OUT MOVEMENT IN THE KNEE FLEXION. IT WAS TESTED BEFORE AND IT DID NOT HAPPEN IN THE TEST WITH THE PROOF POLY SO WE HAD TO OPEN A SECOND POLYETHYLENE OF A HIGHER NUMBER. INITIALLY 5 AND THEN THE FINAL 6. INTRAOPERATIVELY, AFTER ALL PROOF TESTS, THE ITEM SKU (B)(4) (8X5 MM) WAS OPENED, AFTER OPENING AND IMPLANTING IT, THE DOCTOR WAS NOT SATISFIED WITH THE FLEXION EXTENSION AND LIGAMENT BALANCE, CHOOSING TO OPEN ANOTHER 8X6 MM INSERT (B)(4) (MEDICAL DECISION). IN WHICH HE IS THE ONLY ONE IN THE SURGICAL MOMENT THAT HE CAN EVALUATE AND HE REPORTED THIS IN HIS JUSTIFICATION TO THE HOSPITAL. THERE WAS NO HARM TO THE PATIENT'S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218745 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND POLY EXCHANGE WERE PERFORMED. DOI: (B)(6) 2021. DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11992302 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO LOOSENING REPORTED. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11773642 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A POLY SWAP WAS PERFORMED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11711992 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR PROCEDURE INFECTED ATTUNE TOTAL KNEE ARTHROPLASTY RIGHT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11140409 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL KNEE REVISION FOR INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10316332 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION FOR IMPLANTATION OF AN ANTIBIOTIC SPACER DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9598396 ↗
• InjuryNov 8, 2019Unintended Movement; Unintended Movement

  MOBILE BEARING ATTUNE RP REVISED FOR BEARING SPIN OUT. REVISED FEMORAL COMPONENT TO A LARGER PS SIZE AND THICKER POLYETHYLENE BEARING. TIBIAL COMPONENT AND PATELLA REMAINED INSITU.

  Patient problems: No Code Available

  MAUDE report 9297266 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 08 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO ARTHROFIBROSIS, METAL SENSITIVITY, STIFFNESS, AND PAIN. THE SURGEON INDICATED A LARGE AMOUNT OF SYNOVITIS WAS GROWING OVER THE PATELLA AND RESECTED, AS WELL AS INFRAPATELLAR SCARRED PAD. THE PATELLA WAS REDUCED. HE REPORTED THE PATIENT WAS VERY TIGHT IN FLEXION. THE SURGEON REPORTED THE REMOVAL OF THE FEMORAL COMPONENT, OFFERING NO COMPLAINTS ABOUT THE COMPONENT. HE NOTED THE TIBIAL COMPONENT WAS DISASSOCIATED FROM THE CEMENT MANTLE. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND SMARTSET BONE CEMENT X 3. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2017. (LT KNEE).

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9261928 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EARLY ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9166298 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8456793 ↗
• InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Unspecified Infection

  MAUDE report 7903263 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN WITH CHRONIC EFFUSIONS. CEMENT MANUFACTURER IS FROM COMPETITOR. DOI: (B)(6) 2017 DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Pain; Scar Tissue; Swelling

  MAUDE report 7677390 ↗